In a health care facility, sterilization generally refers to the process of eliminating bacteria and other microorganisms from the surfaces of instruments, medical devices, implants and other articles used in surgical procedures. A traditional sterilization process uses steam under pressure. Alternative sterilization processes use ethylene oxide, hydrogen peroxide, hydrogen peroxide/plasma, or peracetic acid in vapor form as the sterilant, as well as gamma irradiation and electron beam sterilization. In each process, the sterilizer is designed to kill all viable living organisms within a sterilization chamber. To achieve this objective, health care personnel must select the appropriate sterilization process and carefully monitor its parameters.
To verify successful sterilization, health care facilities typically use sterilization indicators of either the chemical or biological variety. A chemical sterilization indicator responds to one or more conditions necessary for proper sterilization, such as temperature, time, and sterilant concentration or exposure. A biological indicator carries a biological agent, and indicates successful sterilization when the biological agent has been killed. The indicator is placed on or within a pack containing articles to be sterilized.
Following the sterilization process, the sterilization indicator aids health care personnel in identifying packs that have been exposed to the conditions necessary for sterilization. The pack may carry other information, often within the indicator, that identifies the pack for record-keeping purposes. For example, the indicator may carry text or bar code information that uniquely identifies the pack, and indicates sterilization status. In some cases, the information can be scanned in an automated manner to assist in automated record-keeping via a computer system.
To achieve effective sterilization workflow, record-keeping, and safety, a health care facility must devote substantial personnel, training and administrative resources to the sterilization process. For example, it is necessary to maintain a sufficient inventory of sterilant, pack lists, and indicators, and properly maintain sterilization equipment. Comprehensive knowledge of sterilization procedures and control of associated parameters are necessary for proper sterilization. In addition, efficient workflow requires effective tracking of packs to ensure that sterilized articles are available when needed. Cost accounting also is desirable to allocate the costs of sterilization to appropriate departments or entities. In addition, regulatory agencies and independent audit organizations may require access to sterilization records for verification of regulatory compliance or accreditation. Access to information concerning best practices also is important in maintaining and refining sterilization processes within a sterilization facility.